Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus:
"In Brief, What's This Issue About?
In the US, the Food and Drug Administration (FDA) regulates many products to ensure that they are safe and effective, including medical devices such as wheelchairs and pacemakers. However, the definition of "medical device" also includes software, and in recent years FDA has moved to regulate software found on mobile phones, what most people refer to as "mobile apps."
Critics have raised the point that strict regulation of medical mobile apps could stifle innovation in the sector, while others have pointed to spurious or faulty apps to make the point that regulation is sorely needed."
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